Bottom Line: The U.S. Food and Drug Administration (FDA) created the Breakthrough Therapy designation in 2012 to expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions when preliminary clinical evidence suggested better improvement over existing therapies. This study reviewed the 46 therapeutics with Breakthrough Therapy designation approved by the FDA from 2012 through 2017. Results suggest trials supporting those drugs granted that designation commonly enrolled small numbers of patients and lacked randomization and control groups.

-end-

Authors: Joseph S. Ross, M.D., M.H.S., Yale University School of Medicine, New Haven, Connecticut, and coauthors

To Learn More: The full study is available on the For The Media website.

(doi:10.1001/jama.2018.7619)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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